FDA product code KYE: Inserter/Remover Contact Lens
KYE is the FDA product code for inserter/remover contact lens. It is a Class I device, regulated under 21 CFR 886.5420 and reviewed by the Ophthalmic panel. FDA has cleared 12 510(k) submissions under KYE, from 8 different applicants. The average 510(k) review took 64 days (median 38).
Classification
| Field | Value |
|---|---|
| Device name | Inserter/Remover Contact Lens |
| Device class | Class I |
| Regulation | 21 CFR 886.5420 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KYE clearance
Top KYE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dmv Contact Lens Co. | 3 | 1983-03-09 |
| Magnivision, Inc. | 2 | 1987-08-10 |
| Marlin Industries | 2 | 1985-09-10 |
| S. M. C. Medi-Tech Corp. | 1 | 1987-05-12 |
| Dayton Mfg. Co. | 1 | 1987-02-12 |
3 more applicants have KYE clearances. See the full list in Caduvo.
Most recent KYE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K872567 | Magnivision, Inc. | SOFT CONTACT LENS REMOVER | 1987-08-10 | 42 |
| K872591 | Magnivision, Inc. | HARD CONTACT LENS REMOVER. ITEM #289 | 1987-08-04 | 34 |
| K871130 | S. M. C. Medi-Tech Corp. | CONTACT LENS TWEEZERS | 1987-05-12 | 53 |
| K870072 | Dayton Mfg. Co. | SUMMIT OPTICS CONTACT LENS REMOVER | 1987-02-12 | 35 |
| K850984 | Marlin Industries | MARLIN SOFT LENS HANDLER | 1985-09-10 | 183 |
Recalls for KYE devices
openFDA lists no recalls for product code KYE.
Frequently asked questions
What is FDA product code KYE?
KYE is the FDA product code for inserter/remover contact lens. It is a Class I device, regulated under 21 CFR 886.5420 and reviewed by the Ophthalmic panel.
What device class is KYE?
Class I, regulation 21 CFR 886.5420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KYE?
Across 12 cleared submissions the average was 64 days from receipt to decision (median 38).
Which companies have the most KYE clearances?
Dmv Contact Lens Co. (3); Magnivision, Inc. (2); Marlin Industries (2); S. M. C. Medi-Tech Corp. (1); Dayton Mfg. Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KYE
- Run a recall and safety report across every KYE manufacturer
- Watch product code KYE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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